Clinical Trial

Treatment of Non-Small Cell Lung Cancer

Study Description

A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495)

This study will investigate the utility of biomarker-based triage for study participants with advanced non-small cell lung cancer (NSCLC) without prior systemic therapy. Study participants within groups defined by a biomarker-based classifier (gene expression profile [GEP] and tumor mutational burden [TMB]) will be randomized to receive pembrolizumab in combination with MK-1308, MK-4280, or lenvatinib. The primary hypotheses are as follows: In participants receiving pembrolizumab in combination with either MK-1308, MK-4280, or lenvatinib, the Objective Response Rate (ORR) will be 1) greater than 5% among participants with low GEP and low TMB, 2) greater than 20% among participants with low GEP and high TMB, 3) greater than 20% among participants with high GEP and low TMB, and 4) greater than 45% among participants with high GEP and high TMB.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Biological - Pembrolizumab

200 mg pembrolizumab solution for intravenous (IV) infusion administered Q3W

Biological - MK-4280

200 mg or 800 mg MK-4280 solution for IV infusion administered Q3W

Drug - Lenvatinib

20 mg lenvatinib capsules administered orally once daily

Drug - MK-1308

MK-1308 solution for IV infusion administered at the RP2D (dose and schedule based on study NCT03179436)

Additional Information

Official Study Title

A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab-(MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)

Clinical Trial ID

NCT03516981

ParticipAid ID

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